ES2996893T3 - Dry powder formulation comprising a corticosteroid and a beta-adrenergic for administration by inhalation - Google Patents

Dry powder formulation comprising a corticosteroid and a beta-adrenergic for administration by inhalation Download PDF

Info

Publication number: ES2996893T3
Authority: ES; Spain
Prior art keywords: particles; microns; diameter; micrometers; bdp
Prior art date: 2012-01-25
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.): Active

Application number

ES19167835T

Other languages

English (en)

Spanish (es)

Inventor

Elisa Monari

Anna Maria Cantarelli

Daniela Cocconi

Irene Pasquali

Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)

Chiesi Farmaceutici SpA

Original Assignee

Chiesi Farmaceutici SpA

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

2012-01-25

Filing date

2013-01-23

Publication date

2025-02-13

Family has litigation

First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=47715987&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2996893(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

2013-01-23 Application filed by Chiesi Farmaceutici SpA filed Critical Chiesi Farmaceutici SpA

2025-02-13 Application granted granted Critical

2025-02-13 Publication of ES2996893T3 publication Critical patent/ES2996893T3/es

Status Active legal-status Critical Current

2033-01-23 Anticipated expiration legal-status Critical

Links

239000000203 mixture Substances 0.000 title claims abstract description 75
238000009472 formulation Methods 0.000 title claims abstract description 59
239000000843 powder Substances 0.000 title claims abstract description 31
239000003246 corticosteroid Substances 0.000 title abstract description 5
239000002245 particle Substances 0.000 claims description 118
KUVIULQEHSCUHY-XYWKZLDCSA-N Beclometasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(Cl)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)COC(=O)CC)(OC(=O)CC)[C@@]1(C)C[C@@H]2O KUVIULQEHSCUHY-XYWKZLDCSA-N 0.000 claims description 64
229950000210 beclometasone dipropionate Drugs 0.000 claims description 62
HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 44
RATSWNOMCHFQGJ-TUYNVFRMSA-N (e)-but-2-enedioic acid;n-[2-hydroxy-5-[(1s)-1-hydroxy-2-[[(2s)-1-(4-methoxyphenyl)propan-2-yl]amino]ethyl]phenyl]formamide;dihydrate Chemical compound O.O.OC(=O)\C=C\C(O)=O.C1=CC(OC)=CC=C1C[C@H](C)NC[C@@H](O)C1=CC=C(O)C(NC=O)=C1.C1=CC(OC)=CC=C1C[C@H](C)NC[C@@H](O)C1=CC=C(O)C(NC=O)=C1 RATSWNOMCHFQGJ-TUYNVFRMSA-N 0.000 claims description 33
238000000034 method Methods 0.000 claims description 30
239000004480 active ingredient Substances 0.000 claims description 29
239000010419 fine particle Substances 0.000 claims description 29
WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 claims description 26
239000011362 coarse particle Substances 0.000 claims description 24
235000019359 magnesium stearate Nutrition 0.000 claims description 22
210000003918 fraction a Anatomy 0.000 claims description 15
238000002156 mixing Methods 0.000 claims description 11
IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 10
229940112141 dry powder inhaler Drugs 0.000 claims description 8
238000004519 manufacturing process Methods 0.000 claims description 7
230000008569 process Effects 0.000 claims description 7
229960003610 formoterol fumarate dihydrate Drugs 0.000 claims description 6
229910052757 nitrogen Inorganic materials 0.000 claims description 5
238000001179 sorption measurement Methods 0.000 claims description 3
239000003814 drug Substances 0.000 abstract description 8
229940079593 drug Drugs 0.000 abstract description 7
230000001225 therapeutic effect Effects 0.000 abstract description 6
238000002360 preparation method Methods 0.000 abstract description 5
229960000193 formoterol fumarate Drugs 0.000 description 28
238000009826 distribution Methods 0.000 description 18
238000011282 treatment Methods 0.000 description 12
239000000546 pharmaceutical excipient Substances 0.000 description 11
238000000227 grinding Methods 0.000 description 8
208000006673 asthma Diseases 0.000 description 6
239000011248 coating agent Substances 0.000 description 6
238000000576 coating method Methods 0.000 description 6
208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 6
201000010099 disease Diseases 0.000 description 5
BPZSYCZIITTYBL-UHFFFAOYSA-N formoterol Chemical compound C1=CC(OC)=CC=C1CC(C)NCC(O)C1=CC=C(O)C(NC=O)=C1 BPZSYCZIITTYBL-UHFFFAOYSA-N 0.000 description 5
229960002848 formoterol Drugs 0.000 description 5
238000013459 approach Methods 0.000 description 4
238000000151 deposition Methods 0.000 description 4
239000007788 liquid Substances 0.000 description 4
208000023504 respiratory system disease Diseases 0.000 description 4
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 description 3
239000000443 aerosol Substances 0.000 description 3
230000008901 benefit Effects 0.000 description 3
230000008021 deposition Effects 0.000 description 3
230000002265 prevention Effects 0.000 description 3
239000000126 substance Substances 0.000 description 3
238000012360 testing method Methods 0.000 description 3
208000000884 Airway Obstruction Diseases 0.000 description 2
LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
206010061218 Inflammation Diseases 0.000 description 2
238000004833 X-ray photoelectron spectroscopy Methods 0.000 description 2
239000013543 active substance Substances 0.000 description 2
238000012387 aerosolization Methods 0.000 description 2
238000004458 analytical method Methods 0.000 description 2
230000009286 beneficial effect Effects 0.000 description 2
102000014974 beta2-adrenergic receptor activity proteins Human genes 0.000 description 2
108040006828 beta2-adrenergic receptor activity proteins Proteins 0.000 description 2
230000008859 change Effects 0.000 description 2
238000005056 compaction Methods 0.000 description 2
238000013461 design Methods 0.000 description 2
230000000694 effects Effects 0.000 description 2
230000006872 improvement Effects 0.000 description 2
230000002757 inflammatory effect Effects 0.000 description 2
230000004054 inflammatory process Effects 0.000 description 2
150000004682 monohydrates Chemical class 0.000 description 2
230000000414 obstructive effect Effects 0.000 description 2
239000008188 pellet Substances 0.000 description 2
229940068196 placebo Drugs 0.000 description 2
239000000902 placebo Substances 0.000 description 2
238000012545 processing Methods 0.000 description 2
230000000241 respiratory effect Effects 0.000 description 2
238000004626 scanning electron microscopy Methods 0.000 description 2
238000007873 sieving Methods 0.000 description 2
230000004083 survival effect Effects 0.000 description 2
208000024891 symptom Diseases 0.000 description 2
NWLPAIVRIWBEIT-SEPHDYHBSA-N (e)-but-2-enedioic acid;dihydrate Chemical compound O.O.OC(=O)\C=C\C(O)=O NWLPAIVRIWBEIT-SEPHDYHBSA-N 0.000 description 1
244000020998 Acacia farnesiana Species 0.000 description 1
206010006448 Bronchiolitis Diseases 0.000 description 1
206010006458 Bronchitis chronic Diseases 0.000 description 1
206010061818 Disease progression Diseases 0.000 description 1
-1 FF dihydrate Chemical class 0.000 description 1
VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical class OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 description 1
238000004566 IR spectroscopy Methods 0.000 description 1
GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 1
235000010643 Leucaena leucocephala Nutrition 0.000 description 1
FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical group [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
238000001069 Raman spectroscopy Methods 0.000 description 1
239000011149 active material Substances 0.000 description 1
239000000048 adrenergic agonist Substances 0.000 description 1
239000000556 agonist Substances 0.000 description 1
230000003266 anti-allergic effect Effects 0.000 description 1
239000002260 anti-inflammatory agent Substances 0.000 description 1
239000000043 antiallergic agent Substances 0.000 description 1
229940065524 anticholinergics inhalants for obstructive airway diseases Drugs 0.000 description 1
NBMKJKDGKREAPL-DVTGEIKXSA-N beclomethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(Cl)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O NBMKJKDGKREAPL-DVTGEIKXSA-N 0.000 description 1
102000016966 beta-2 Adrenergic Receptors Human genes 0.000 description 1
108010014499 beta-2 Adrenergic Receptors Proteins 0.000 description 1
210000000621 bronchi Anatomy 0.000 description 1
206010006451 bronchitis Diseases 0.000 description 1
229940124630 bronchodilator Drugs 0.000 description 1
239000000168 bronchodilator agent Substances 0.000 description 1
239000002775 capsule Substances 0.000 description 1
239000000812 cholinergic antagonist Substances 0.000 description 1
208000007451 chronic bronchitis Diseases 0.000 description 1
230000001684 chronic effect Effects 0.000 description 1
150000001875 compounds Chemical class 0.000 description 1
230000003750 conditioning effect Effects 0.000 description 1
229960001334 corticosteroids Drugs 0.000 description 1
239000006184 cosolvent Substances 0.000 description 1
238000005336 cracking Methods 0.000 description 1
230000001186 cumulative effect Effects 0.000 description 1
150000004683 dihydrates Chemical class 0.000 description 1
230000005750 disease progression Effects 0.000 description 1
208000035475 disorder Diseases 0.000 description 1
238000001803 electron scattering Methods 0.000 description 1
238000011156 evaluation Methods 0.000 description 1
230000005713 exacerbation Effects 0.000 description 1
239000010408 film Substances 0.000 description 1
239000013020 final formulation Substances 0.000 description 1
239000012530 fluid Substances 0.000 description 1
DYDNPESBYVVLBO-UHFFFAOYSA-N formanilide Chemical compound O=CNC1=CC=CC=C1 DYDNPESBYVVLBO-UHFFFAOYSA-N 0.000 description 1
238000004128 high performance liquid chromatography Methods 0.000 description 1
239000008240 homogeneous mixture Substances 0.000 description 1
238000010191 image analysis Methods 0.000 description 1
238000000338 in vitro Methods 0.000 description 1
208000030603 inherited susceptibility to asthma Diseases 0.000 description 1
229960001375 lactose Drugs 0.000 description 1
239000008101 lactose Substances 0.000 description 1
238000011068 loading method Methods 0.000 description 1
210000004072 lung Anatomy 0.000 description 1
230000004199 lung function Effects 0.000 description 1
238000005259 measurement Methods 0.000 description 1
238000000386 microscopy Methods 0.000 description 1
210000003097 mucus Anatomy 0.000 description 1
238000012856 packing Methods 0.000 description 1
230000035515 penetration Effects 0.000 description 1
230000002093 peripheral effect Effects 0.000 description 1
238000009522 phase III clinical trial Methods 0.000 description 1
230000003389 potentiating effect Effects 0.000 description 1
125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 1
238000011321 prophylaxis Methods 0.000 description 1
230000002685 pulmonary effect Effects 0.000 description 1
238000005549 size reduction Methods 0.000 description 1
239000007787 solid Substances 0.000 description 1
239000011877 solvent mixture Substances 0.000 description 1
238000005563 spheronization Methods 0.000 description 1
230000002269 spontaneous effect Effects 0.000 description 1
230000003068 static effect Effects 0.000 description 1
239000000758 substrate Substances 0.000 description 1
231100001274 therapeutic index Toxicity 0.000 description 1
239000010409 thin film Substances 0.000 description 1
238000009827 uniform distribution Methods 0.000 description 1
238000005406 washing Methods 0.000 description 1

Classifications

- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0003—Details of inhalators; Constructional features thereof with means for dispensing more than one drug
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
- A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/06—Solids
- A61M2202/064—Powder
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics

Landscapes

Health & Medical Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Veterinary Medicine (AREA)
Animal Behavior & Ethology (AREA)
General Health & Medical Sciences (AREA)
Public Health (AREA)
Engineering & Computer Science (AREA)
Chemical & Material Sciences (AREA)
Pharmacology & Pharmacy (AREA)
Medicinal Chemistry (AREA)
Bioinformatics & Cheminformatics (AREA)
Epidemiology (AREA)
Pulmonology (AREA)
Pain & Pain Management (AREA)
General Chemical & Material Sciences (AREA)
Chemical Kinetics & Catalysis (AREA)
Hematology (AREA)
Anesthesiology (AREA)
Biomedical Technology (AREA)
Heart & Thoracic Surgery (AREA)
Otolaryngology (AREA)
Organic Chemistry (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Biochemistry (AREA)
Molecular Biology (AREA)
Oil, Petroleum & Natural Gas (AREA)
Medicinal Preparation (AREA)
Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

ES19167835T 2012-01-25 2013-01-23 Dry powder formulation comprising a corticosteroid and a beta-adrenergic for administration by inhalation Active ES2996893T3 (en)

Applications Claiming Priority (1)

Application Number	Priority Date	Filing Date	Title
EP12152392		2012-01-25

Publications (1)

Publication Number	Publication Date
ES2996893T3 true ES2996893T3 (en)	2025-02-13

Family

ID=47715987

Family Applications (6)

Application Number	Title	Priority Date	Filing Date
ES19167835T Active ES2996893T3 (en)	2012-01-25	2013-01-23	Dry powder formulation comprising a corticosteroid and a beta-adrenergic for administration by inhalation
ES19167829T Active ES2929137T3 (es)	2012-01-25	2013-01-23	Formulación en polvo seco que comprende un corticoesteroide y un beta-adrenérgico para administración por inhalación
ES19167775T Active ES2928688T3 (es)	2012-01-25	2013-01-23	Formulación en polvo seca que comprende un corticoesteroide y un beta-adrenérgico para administración por inhalación
ES19167839T Active ES2929807T3 (es)	2012-01-25	2013-01-23	Formulación en polvo seco que comprende un corticoesteroide y un beta-adrenérgico para administración por inhalación
ES13704372.5T Active ES2683254T3 (es)	2012-01-25	2013-01-23	Formulación en polvo seca que comprende un corticoesteroide y un beta-adrenérgico para administración por inhalación
ES18181331T Active ES2938466T3 (es)	2012-01-25	2013-01-23	Formulación en polvo seco que comprende un corticoesteroide y un beta-adrenérgico para administración por inhalación

Family Applications After (5)

Application Number	Title	Priority Date	Filing Date
ES19167829T Active ES2929137T3 (es)	2012-01-25	2013-01-23	Formulación en polvo seco que comprende un corticoesteroide y un beta-adrenérgico para administración por inhalación
ES19167775T Active ES2928688T3 (es)	2012-01-25	2013-01-23	Formulación en polvo seca que comprende un corticoesteroide y un beta-adrenérgico para administración por inhalación
ES19167839T Active ES2929807T3 (es)	2012-01-25	2013-01-23	Formulación en polvo seco que comprende un corticoesteroide y un beta-adrenérgico para administración por inhalación
ES13704372.5T Active ES2683254T3 (es)	2012-01-25	2013-01-23	Formulación en polvo seca que comprende un corticoesteroide y un beta-adrenérgico para administración por inhalación
ES18181331T Active ES2938466T3 (es)	2012-01-25	2013-01-23	Formulación en polvo seco que comprende un corticoesteroide y un beta-adrenérgico para administración por inhalación

Country Status (37)

Country	Link
US (3)	US10028964B2 (sr)
EP (7)	EP3527198B1 (sr)
JP (1)	JP6104282B2 (sr)
KR (3)	KR101560288B1 (sr)
CN (2)	CN105726548B (sr)
AR (1)	AR089805A1 (sr)
AU (1)	AU2013211656B2 (sr)
BR (1)	BR112014017481A8 (sr)
CA (1)	CA2862548C (sr)
CL (1)	CL2014001966A1 (sr)
CO (1)	CO7010836A2 (sr)
CY (3)	CY1120684T1 (sr)
DK (6)	DK3527197T3 (sr)
EA (2)	EA026267B1 (sr)
ES (6)	ES2996893T3 (sr)
FI (2)	FI3412277T3 (sr)
GE (1)	GEP201706767B (sr)
HR (6)	HRP20221432T1 (sr)
HU (6)	HUE069624T2 (sr)
IL (1)	IL233784A0 (sr)
LT (5)	LT3527197T (sr)
MA (1)	MA35859B1 (sr)
MX (2)	MX355729B (sr)
MY (1)	MY165888A (sr)
NZ (1)	NZ627837A (sr)
PE (1)	PE20141703A1 (sr)
PH (1)	PH12014501565B1 (sr)
PL (6)	PL3527198T3 (sr)
PT (6)	PT3527196T (sr)
RS (5)	RS63952B1 (sr)
SG (1)	SG11201404350PA (sr)
SI (3)	SI2806855T1 (sr)
TN (1)	TN2014000322A1 (sr)
TW (1)	TWI559940B (sr)
UA (1)	UA115543C2 (sr)
WO (1)	WO2013110632A1 (sr)
ZA (1)	ZA201405464B (sr)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
HUE069624T2 (hu) *	2012-01-25	2025-03-28	Chiesi Farm Spa	Kortikoszteroidot és béta-adrenerg szert tartalmazó száraz porkészítmény inhalálással történõ beadásra
LT3019153T (lt)	2013-07-11	2018-11-26	Chiesi Farmaceutici S.P.A.	Sausų miltelių kompozicija, apimanti anticholinerginį agentą, kortikosteroidą ir beta-adrenerginį agentą, skirta įvedimui inhaliacijos pagalba
UA118861C2 (uk) *	2013-12-06	2019-03-25	Оріон Корпорейшн	Спосіб отримання сухих порошкових композицій для інгаляцій
KR102462058B1 (ko)	2014-10-08	2022-11-01	잠본쏘시에떼퍼아찌오니	제제의 안정성을 증가시키기 위해 분무 건조에 의해 수득된 1종 이상의 건조 분말을 포함하는 조성물
WO2018059390A1 (zh) *	2016-09-29	2018-04-05	广东东阳光药业有限公司	药物组合物
WO2018206618A1 (en) *	2017-05-11	2018-11-15	Chiesi Farmaceutici S.P.A.	A process for preparing a dry powder formulation comprising an anticholinergic, a corticosteroid and a beta-adrenergic
US11931368B2 (en)	2017-09-29	2024-03-19	Crititech, Inc.	Glucocorticoid “nintedanib” particles and their use
ES2953293T3 (es) *	2018-08-07	2023-11-10	Norton Waterford Ltd	Aplicación de espectroscopia Raman para la fabricación de polvos para inhalación
WO2020088984A1 (en)	2018-10-30	2020-05-07	Chiesi Farmaceutici S.P.A.	Apparatus to administer drugs to mechanically ventilated patients
MX2022003427A (es)	2019-09-24	2022-04-18	Chiesi Farm Spa	Particulas portadoras novedosas para formulaciones de polvo seco para inhalacion.
GB202012742D0 (en)	2020-08-14	2020-09-30	Norton Waterford Ltd	An inhalable medicament
US20250050042A1 (en) *	2021-12-21	2025-02-13	Chiesi Farmaceutici S.P.A.	Dry powder formulations filled in an inhaler with improved resistance to humidity

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
GB9501841D0 (en) *	1995-01-31	1995-03-22	Co Ordinated Drug Dev	Improvements in and relating to carrier particles for use in dry powder inhalers
CN1150895C (zh) *	1998-11-13	2004-05-26	杰格研究股份公司	用于吸入给药的干粉
IT1309592B1 (it) *	1999-03-05	2002-01-24	Chiesi Farma Spa	Particelle veicolo modificate da utilizzarsi nella preparazione diformulazioni farmaceutiche sotto forma di polimeri per inalazione e
PE20011227A1 (es) *	2000-04-17	2002-01-07	Chiesi Farma Spa	Formulaciones farmaceuticas para inhaladores de polvo seco en la forma de aglomerados duros
GB0015043D0 (en)	2000-06-21	2000-08-09	Glaxo Group Ltd	Medicament dispenser
FI20002215A0 (fi) *	2000-10-06	2000-10-06	Orion Yhtymae Oyj	Yhdistelmäpartikkelit
PT1386630E (pt)	2002-07-31	2006-09-29	Chiesi Farma Spa	Inalador em po
JO3102B1 (ar) *	2004-03-17	2017-09-20	Chiesi Framaceutici S P A	صيغ صيدلانية لوسائل استنشاق بها مسحوق جاف تشتمل على مكون فعال بقوة منخفضة الجرعة
ES2257152B1 (es) *	2004-05-31	2007-07-01	Laboratorios Almirall S.A.	Combinaciones que comprenden agentes antimuscarinicos y agonistas beta-adrenergicos.
EP1944018A1 (en) *	2007-01-10	2008-07-16	CHIESI FARMACEUTICI S.p.A.	Micronised particles of low-dosage strength active agents for powder formulations for inhalation
EP1982709A1 (en) *	2007-04-19	2008-10-22	CHIESI FARMACEUTICI S.p.A.	Use of a composition comprising formoterol and beclomethasone dipropionate for the prevention or treatment of an acute condition of asthma
WO2010097188A1 (en) *	2009-02-25	2010-09-02	Chiesi Farmaceutici S.P.A.	Inhalation particles comprising a salt of carmoterol and a corticosteroid
US9101539B2 (en) *	2009-05-15	2015-08-11	Shin Nippon Biomedical Laboratories, Ltd.	Intranasal pharmaceutical compositions with improved pharmacokinetics
GB0914240D0 (en) *	2009-08-14	2009-09-30	Breath Ltd	Steroid solvates
WO2011038872A1 (en) *	2009-10-02	2011-04-07	Chiesi Farmaceutici S.P.A.	Pharmaceutical aerosol formulations of formoterol and beclometasone dipropionate
WO2011120779A1 (en) *	2010-04-01	2011-10-06	Chiesi Farmaceutici S.P.A.	Process for preparing carrier particles for dry powders for inhalation
RU2580312C2 (ru)	2010-04-21	2016-04-10	КЬЕЗИ ФАРМАЧЕУТИЧИ С.п.А.	Способ получения частиц с пониженным электростатическим зарядом
HUE069624T2 (hu) *	2012-01-25	2025-03-28	Chiesi Farm Spa	Kortikoszteroidot és béta-adrenerg szert tartalmazó száraz porkészítmény inhalálással történõ beadásra
LT3019153T (lt) *	2013-07-11	2018-11-26	Chiesi Farmaceutici S.P.A.	Sausų miltelių kompozicija, apimanti anticholinerginį agentą, kortikosteroidą ir beta-adrenerginį agentą, skirta įvedimui inhaliacijos pagalba

2013
- 2013-01-23 HU HUE19167835A patent/HUE069624T2/hu unknown
- 2013-01-23 PL PL19167835.8T patent/PL3527198T3/pl unknown
- 2013-01-23 PL PL13704372T patent/PL2806855T3/pl unknown
- 2013-01-23 MX MX2014008631A patent/MX355729B/es active IP Right Grant
- 2013-01-23 RS RS20230066A patent/RS63952B1/sr unknown
- 2013-01-23 ES ES19167835T patent/ES2996893T3/es active Active
- 2013-01-23 MY MYPI2014002176A patent/MY165888A/en unknown
- 2013-01-23 PL PL19167829.1T patent/PL3527197T3/pl unknown
- 2013-01-23 HU HUE18181331A patent/HUE061566T2/hu unknown
- 2013-01-23 LT LTEP19167829.1T patent/LT3527197T/lt unknown
- 2013-01-23 PT PT191677756T patent/PT3527196T/pt unknown
- 2013-01-23 SG SG11201404350PA patent/SG11201404350PA/en unknown
- 2013-01-23 GE GEAP201313532A patent/GEP201706767B/en unknown
- 2013-01-23 UA UAA201408448A patent/UA115543C2/uk unknown
- 2013-01-23 BR BR112014017481A patent/BR112014017481A8/pt not_active Application Discontinuation
- 2013-01-23 LT LTEP13704372.5T patent/LT2806855T/lt unknown
- 2013-01-23 HU HUE19167775A patent/HUE060402T2/hu unknown
- 2013-01-23 HR HRP20221432TT patent/HRP20221432T1/hr unknown
- 2013-01-23 ES ES19167829T patent/ES2929137T3/es active Active
- 2013-01-23 WO PCT/EP2013/051187 patent/WO2013110632A1/en not_active Ceased
- 2013-01-23 PT PT191678358T patent/PT3527198T/pt unknown
- 2013-01-23 RS RS20181038A patent/RS57637B1/sr unknown
- 2013-01-23 ES ES19167775T patent/ES2928688T3/es active Active
- 2013-01-23 DK DK19167829.1T patent/DK3527197T3/da active
- 2013-01-23 HR HRP20221433TT patent/HRP20221433T1/hr unknown
- 2013-01-23 FI FIEP18181331.2T patent/FI3412277T3/fi active
- 2013-01-23 KR KR1020147019763A patent/KR101560288B1/ko active Active
- 2013-01-23 LT LTEP19167839.0T patent/LT3527199T/lt unknown
- 2013-01-23 SI SI201331186T patent/SI2806855T1/sl unknown
- 2013-01-23 EP EP19167835.8A patent/EP3527198B1/en active Active
- 2013-01-23 AU AU2013211656A patent/AU2013211656B2/en active Active
- 2013-01-23 FI FIEP19167835.8T patent/FI3527198T3/fi active
- 2013-01-23 MX MX2016001311A patent/MX368199B/es unknown
- 2013-01-23 RS RS20220971A patent/RS63706B1/sr unknown
- 2013-01-23 KR KR1020157019169A patent/KR101786586B1/ko active Active
- 2013-01-23 PT PT191678291T patent/PT3527197T/pt unknown
- 2013-01-23 NZ NZ627837A patent/NZ627837A/en unknown
- 2013-01-23 PT PT181813312T patent/PT3412277T/pt unknown
- 2013-01-23 PL PL18181331.2T patent/PL3412277T3/pl unknown
- 2013-01-23 PT PT191678390T patent/PT3527199T/pt unknown
- 2013-01-23 LT LTEP19167775.6T patent/LT3527196T/lt unknown
- 2013-01-23 HR HRP20230147TT patent/HRP20230147T1/hr unknown
- 2013-01-23 HR HRP20221431TT patent/HRP20221431T1/hr unknown
- 2013-01-23 HU HUE19167829A patent/HUE060421T2/hu unknown
- 2013-01-23 EP EP15202117.6A patent/EP3020394A1/en not_active Withdrawn
- 2013-01-23 HU HUE19167839A patent/HUE060705T2/hu unknown
- 2013-01-23 SI SI201332092T patent/SI3527198T1/sl unknown
- 2013-01-23 PE PE2014001166A patent/PE20141703A1/es active IP Right Grant
- 2013-01-23 HR HRP20181550TT patent/HRP20181550T1/hr unknown
- 2013-01-23 SI SI201332032T patent/SI3412277T1/sl unknown
- 2013-01-23 CN CN201610080909.1A patent/CN105726548B/zh active Active
- 2013-01-23 US US14/417,484 patent/US10028964B2/en active Active
- 2013-01-23 RS RS20221007A patent/RS63761B1/sr unknown
- 2013-01-23 DK DK19167839.0T patent/DK3527199T3/da active
- 2013-01-23 ES ES19167839T patent/ES2929807T3/es active Active
- 2013-01-23 HR HRP20241638TT patent/HRP20241638T1/hr unknown
- 2013-01-23 PL PL19167839.0T patent/PL3527199T3/pl unknown
- 2013-01-23 CA CA2862548A patent/CA2862548C/en active Active
- 2013-01-23 PT PT137043725T patent/PT2806855T/pt unknown
- 2013-01-23 PL PL19167775.6T patent/PL3527196T3/pl unknown
- 2013-01-23 EP EP18181331.2A patent/EP3412277B1/en active Active
- 2013-01-23 LT LTEP18181331.2T patent/LT3412277T/lt unknown
- 2013-01-23 HU HUE13704372A patent/HUE040525T2/hu unknown
- 2013-01-23 EP EP19167775.6A patent/EP3527196B1/en active Active
- 2013-01-23 DK DK13704372.5T patent/DK2806855T3/en active
- 2013-01-23 EP EP13704372.5A patent/EP2806855B1/en active Active
- 2013-01-23 RS RS20221033A patent/RS63759B1/sr unknown
- 2013-01-23 EA EA201491281A patent/EA026267B1/ru unknown
- 2013-01-23 KR KR1020177027831A patent/KR101895279B1/ko active Active
- 2013-01-23 EP EP19167839.0A patent/EP3527199B1/en active Active
- 2013-01-23 JP JP2014553692A patent/JP6104282B2/ja active Active
- 2013-01-23 DK DK19167775.6T patent/DK3527196T3/da active
- 2013-01-23 DK DK19167835.8T patent/DK3527198T3/da active
- 2013-01-23 EP EP19167829.1A patent/EP3527197B1/en active Active
- 2013-01-23 CN CN201380006645.XA patent/CN104080444B/zh active Active
- 2013-01-23 ES ES13704372.5T patent/ES2683254T3/es active Active
- 2013-01-23 ES ES18181331T patent/ES2938466T3/es active Active
- 2013-01-23 DK DK18181331.2T patent/DK3412277T3/da active
- 2013-01-23 EA EA201690187A patent/EA031566B1/ru unknown
- 2013-01-24 US US13/748,882 patent/US8778402B2/en active Active
- 2013-01-24 AR ARP130100225A patent/AR089805A1/es not_active Application Discontinuation
- 2013-01-24 TW TW102102606A patent/TWI559940B/zh active
2014
- 2014-07-07 PH PH12014501565A patent/PH12014501565B1/en unknown
- 2014-07-11 MA MA37200A patent/MA35859B1/fr unknown
- 2014-07-24 ZA ZA2014/05464A patent/ZA201405464B/en unknown
- 2014-07-24 TN TNP2014000322A patent/TN2014000322A1/fr unknown
- 2014-07-24 CO CO14161092A patent/CO7010836A2/es unknown
- 2014-07-24 CL CL2014001966A patent/CL2014001966A1/es unknown
- 2014-07-24 IL IL233784A patent/IL233784A0/en active IP Right Grant
2018
- 2018-06-22 US US16/015,666 patent/US10946029B2/en active Active
- 2018-09-11 CY CY181100948T patent/CY1120684T1/el unknown
2022
- 2022-09-29 CY CY20221100643T patent/CY1125579T1/el unknown
- 2022-10-05 CY CY20221100663T patent/CY1125595T1/el unknown

Also Published As

Publication number	Publication date
AU2013211656B2 (en)	2017-07-13
HRP20221433T1 (hr)	2023-01-06
EP2806855A1 (en)	2014-12-03
PT3527199T (pt)	2022-11-08
HUE060402T2 (hu)	2023-02-28
TWI559940B (en)	2016-12-01
PL3527199T3 (pl)	2022-12-12
EA026267B1 (ru)	2017-03-31
DK3527197T3 (da)	2022-10-24
PE20141703A1 (es)	2014-11-24
EP3020394A1 (en)	2016-05-18
EA201690187A1 (ru)	2016-05-31
SI3527198T1 (sl)	2025-03-31
ES2929807T3 (es)	2022-12-01
PL2806855T3 (pl)	2018-12-31
EP3527199A1 (en)	2019-08-21
RS63706B1 (sr)	2022-11-30
HRP20230147T1 (hr)	2023-03-31
LT3527199T (lt)	2022-12-12
CN105726548A (zh)	2016-07-06
JP2015508416A (ja)	2015-03-19
ES2929137T3 (es)	2022-11-25
RS63759B1 (sr)	2022-12-30
LT3527197T (lt)	2022-11-25
EP3527196B1 (en)	2022-09-07
LT2806855T (lt)	2018-10-10
EA031566B1 (ru)	2019-01-31
CO7010836A2 (es)	2014-07-31
PH12014501565A1 (en)	2014-10-08
FI3527198T3 (fi)	2024-12-13
US20180296573A1 (en)	2018-10-18
CY1125579T1 (el)	2026-02-25
JP6104282B2 (ja)	2017-03-29
PH12014501565B1 (en)	2014-10-08
US20130189324A1 (en)	2013-07-25
HRP20221432T1 (hr)	2023-01-06
DK3527199T3 (da)	2022-10-24
EA201491281A1 (ru)	2014-12-30
EP3527197A1 (en)	2019-08-21
KR20170116234A (ko)	2017-10-18
PL3412277T3 (pl)	2023-06-19
AU2013211656A1 (en)	2014-07-24
HUE060421T2 (hu)	2023-02-28
CA2862548A1 (en)	2013-08-01
NZ627837A (en)	2016-04-29
HUE040525T2 (hu)	2019-03-28
PT3527198T (pt)	2024-12-04
SG11201404350PA (en)	2014-08-28
PT2806855T (pt)	2018-09-28
MX355729B (es)	2018-04-27
CN105726548B (zh)	2019-05-14
HRP20221431T1 (hr)	2023-01-06
MY165888A (en)	2018-05-18
BR112014017481A8 (pt)	2021-06-15
ES2938466T3 (es)	2023-04-11
HRP20241638T1 (hr)	2025-02-14
CL2014001966A1 (es)	2014-11-14
DK3527198T3 (da)	2024-10-28
ZA201405464B (en)	2015-12-23
SI3412277T1 (sl)	2023-03-31
US10946029B2 (en)	2021-03-16
KR20150089093A (ko)	2015-08-04
CY1125595T1 (el)	2026-02-25
PT3412277T (pt)	2023-02-14
US8778402B2 (en)	2014-07-15
FI3412277T3 (fi)	2023-03-23
ES2928688T3 (es)	2022-11-22
ES2683254T3 (es)	2018-09-25
GEP201706767B (en)	2017-11-10
DK3527196T3 (da)	2022-10-24
HUE060705T2 (hu)	2023-04-28
HUE069624T2 (hu)	2025-03-28
RS63952B1 (sr)	2023-02-28
EP3527199B1 (en)	2022-09-07
US10028964B2 (en)	2018-07-24
WO2013110632A1 (en)	2013-08-01
KR101560288B1 (ko)	2015-10-14
MX2014008631A (es)	2014-08-21
KR101895279B1 (ko)	2018-09-05
KR20140114374A (ko)	2014-09-26
EP3412277A1 (en)	2018-12-12
RS63761B1 (sr)	2022-12-30
BR112014017481A2 (pt)	2017-06-13
CN104080444A (zh)	2014-10-01
PL3527198T3 (pl)	2025-01-27
LT3527196T (lt)	2022-11-25
EP3412277B1 (en)	2022-12-14
MA35859B1 (fr)	2014-12-01
EP3527197B1 (en)	2022-09-07
EP3527198B1 (en)	2024-10-09
CA2862548C (en)	2020-07-07
PL3527196T3 (pl)	2022-11-21
MX368199B (es)	2019-09-24
TN2014000322A1 (en)	2015-12-21
RS57637B1 (sr)	2018-11-30
UA115543C2 (uk)	2017-11-27
EP2806855B1 (en)	2018-07-11
EP3527196A1 (en)	2019-08-21
HUE061566T2 (hu)	2023-07-28
AR089805A1 (es)	2014-09-17
KR101786586B1 (ko)	2017-10-18
TW201334810A (zh)	2013-09-01
US20150164915A1 (en)	2015-06-18
CN104080444B (zh)	2017-06-20
HK1200021A1 (en)	2015-07-31
DK3412277T3 (da)	2023-02-20
PT3527196T (pt)	2022-10-18
DK2806855T3 (en)	2018-09-03
LT3412277T (lt)	2023-04-25
PT3527197T (pt)	2022-10-26
HRP20181550T1 (hr)	2018-11-30
PL3527197T3 (pl)	2022-11-21
IL233784A0 (en)	2014-09-30
CY1120684T1 (el)	2019-12-11
SI2806855T1 (sl)	2018-11-30
EP3527198A1 (en)	2019-08-21